The present invention relates generally to breathing devices and, more particularly, to a uniquely-configured nasal mask which is specifically adapted to provide improved sealing to the nasal area of a patient in order to enhance the treatment of certain respiratory conditions.
The use of a breathing apparatus upon respiratory-impaired patients is well known. Generally, such apparatuses assist in patient breathing by allowing proper exchange of inhaled and exhaled gas while providing pressurized gasses to the patient's lungs so as to prevent lung collapse during breathing. In one embodiment, such breathing apparatuses allow spontaneous breathing of the patient while sustaining the application of continuous positive airway pressure (CPAP) to the patient's lungs. CPAP therapy functions primarily to establish an open airway in the patient by delivering continuous flow of gasses such as humidified oxygen in combination with other gasses.
CPAP devices typically include a gas source such as a blower unit which is connected to the user interface by a tubing member such as a gas supply tube. The user interface can be configured for invasive or non-invasive CPAP therapy. For invasive CPAP therapy, gas may be delivered to the patient via a tracheal tube or a pair of nasopharyngeal prongs. For non-invasive CPAP therapy, gas may be delivered to the patient via a conventional nasal mask or a pair of nasal prongs. In either configuration, gas is ideally delivered to the patient at a constant and stable pressure.
Both the nasal mask and nasal prongs are specifically configured to deliver a flow of pressurized gas to the nasal area of the patient. With nasal prongs, pressurized gas is preferably directed into the patient's nostrils through a pair of nostril-engaging prongs or stems which are typically configured to anatomically conform to the interior of the patient's nostrils. Nasal masks as conventionally known are generally triangularly-shaped and, ideally, are sized and configured to substantially envelope and seal around the patient's nose.
The ability to supply pressurized gas to the airways of the patient on a constant basis and at a stable pressure is critical in the effectiveness of CPAP ventilation. The ability to provide constant CPAP therapy is especially important in treating certain respiratory conditions in neonate and infants such as respiratory distress syndrome (RDS). Nasal CPAP therapy is proven as an effective treatment for RSD by developing and restoring functional respiratory capacity through the supply of constant pressure to the neonates airway. Furthermore, nasal CPAP is one of the more easily-administered and one of the best-tolerated respiratory treatment methods amongst infants.
Unfortunately, despite it effectiveness, conventional nasal masks and nasal prongs possess certain deficiencies which detract from their overall utility. One of the most common deficiencies associated with conventional nasal CPAP is improper administration thereof due to poor sealing of nasal masks and nasal prongs at the patient. The improper administration of nasal CPAP can result in serious injuries and complications when misapplied over extended periods of time. For example, nasal masks, and/or nasal prongs may be secured to the patient using a system of straps which are secured around the patient's head in order to maintain position of the nasal mask and/or nasal prongs against the patient's nose such that a proper seal is maintained.
If adjusted too tightly, the straps can create excessive pressure against the patient's face which is particularly problematic for nasal prongs. More particularly, if the straps are adjusted too tightly around the patient's head, the nasal prongs may be forced upwardly into the patient's nostrils which can result in irritation of the tender mucus tissue lining the patient's nostrils. Over extended periods of time (i.e. hours up to days), excessive pressure exerted by nasal prongs against the nasal septum can cause septal erosion as well as cause damage to the lateral walls of the nostrils. In addition, prolonged use of ill-fitting nasal prongs can result in nasal flaring, nasal snubbing and other injuries. An overly-tightened nasal mask can also result in similar nasal trauma including the above-mentioned injury associated with septal erosion.
As was earlier mentioned, the ability to apply CPAP therapy at a constant pressure over extended periods of time is critical in treating certain patients such as premature infants who are especially prone to RDS. The above-mentioned problems associated with an overly-tightened nasal mask or nasal prongs may result from an attempt by caregivers (e.g., family members, nurses) to provide an effective seal against the patient's face to prevent leakage of gas. As is well known in the art, excessively low pressure at the patient can drastically reduce the effectiveness of CPAP therapy.
Low pressure at the patient can result from leaks as a result of improper fitment or positioning of the nasal mask and/or nasal prongs against the patient. Leaks can also be generated at the patient as a result of normal patient movement. The ability to provide leak-free sealing can also result from the relatively wide range of facial structures and sizes amongst different patents and the limited number of commercially-available mask configurations that can accommodate the different facial structures and sizes. Leakage can also be a result from normal patient movements. In particular, infants who make frequent jerking and shaking movements as a part of their physical development can cause difficulty in maintaining a comfortable and leak-free seal of a nasal mask or nasal prongs.
As can be seen, there exists a need in the art for a nasal mask and/or nasal prongs that can provide an effective seal against the patient's face without excessive leakage. Furthermore, there exists a need in the art for a nasal mask which provides such effective sealing without the imposition of undue pressure against the patient's face. Additionally, there exists a need in the art for a nasal mask capable of anatomically conforming to a wide range of facial structures and sizes without leakage. Finally, there exists a need in the art for a nasal mask which is of simple construction, low cost and which is conveniently installable and which maintains a leak-free seal despite normal patient movement.